Quality Assurance Executive (ISO13485)

at  LABGISTICS ASIA PTE LTD

INTERNAL PROCESSES AND REPORTING

• Maintain overall both Singapore and regional Business Entities’ Quality System through review, revision and update of quality management procedures and documentation which comprises of System Procedures (SPs), Standard Operating Procedures (SOPs) and Work Instructions (WI).
• Work with process owner(s) to establish new or revision of quality management processes and procedures.
• Review quality management processes to improve its effectiveness and efficiency.
• Plan and conduct yearly routine internal audits and inspections, scheduled quality audits, mock recalls and traceability exercises and follow up with audit report and ensure audit closure.
• Plan, prepare and coordinate external audits by regulatory bodies and customers and to track and monitor follow-up actions required to close out the audits.
• Track and manage deviations, CAPAs and customer complaints ensuring effective resolution through verification of the effectiveness of corrective and/or preventive actions.
• Lead investigation of all quality deviations and/or non-conformances detected and work with stakeholder(s) on root cause analysis and eliminate such deviations.
• Prepare and conduct Management Review with input from stakeholders and follow up with action items for closure.
• Monitor and track all QA deliverables and activities and conduct necessary follow through until closure to ensure QA KPI targets are met.
• Address quality and compliance related queries and concerns from internal stakeholders, customers and regulatory bodies and advice process owners on documentation related issues.
• Track and monitor both Singapore and Regional KPIs including Quality Assurance performance and develop monthly and/or quarterly analysis and reports for reporting to Management.

REQUIREMENTS

• Bachelor’s degree Science, Engineering-related field or equivalent experience
• Familiar with ISO 9001: 2015 / ISO 13485: 2016 /GDP/GDPMDS/GMP requirements.
• Experience or familiar with leading the internal audit for above standards would be highly advantageous
• Familiarity with quality management methodologies (e.g., Six Sigma, Lean, Root Cause Analysis) is a plus.
• Proficient in MS Office Applications (MS Word, Excel, Powerpoint)
• 2-3 years of relevant experience preferred.
• Strong analytical skills and attention to details.
• Excellent communication and interpersonal skills with ability to work collaboratively and influence cross-functional teams.
• Proficiency in data analysis and reporting tools.
• Problem-solving mindset and the ability to drive continuous improvement.
• This role will be based at 100H Pasir Panjang Rd, #07-01 OC@Pasir Panjang, Singapore 118524

Please refer the Job description for details